EAL

H/A: Dietary Intake (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To investigate the relationship between adherence to a Mediterranean diet and body-shape changes in HIV-infected patients treated with combination antiretroviral therapy (CART) in Croatia.

Inclusion Criteria:

Adults with HIV-1 infection who were treated with combination antiretroviral therapy (CART) for at least one year
Older than 18 years of age.

Exclusion Criteria:

Pregnant and breastfeeding women
Patients with uncontrolled opportunistic infections
Patients with disseminated malignancies.

Description of Study Protocol:

Recruitment

Patients were recruited from the Outpatient HIV/AIDS Department at the University Hospital of Infectious Diseases in Zagreb, Croatia from May 2004 to June 2005. Since all HIV-infected patients in Croatia are treated at UHID, subjects were enrolled from throughout the country.

Design

Cross-sectional study.

Statistical Analysis

Frequency distributions were used for descriptive analysis and medians and inter-quartile ranges for continuous variables such as dietary and energy expenditure
To compare different characteristics of participants with lipoatrophy or lipohypertrophy to those without these conditions, the Wilcoxon rank sum test was used for continuous variables and the Fisher's exact test or Chi-square test for categorical variables were used
The adequacy of the final models was assessed by the Hosmer-Lemeshow test and checked for outliers and multi-collinearity.

Data Collection Summary:

Timing of Measurements

Cross-sectional study conducted between May 2004 and June 2005.

Dependent Variables

Lipoatrophy and lipohypertrophy were assessed by self-report and physical examination
Physical examination also included measurements of waist and hip circumference, weight and height
Blood drawn for CD4 cell count and HIV-1 RNA levels.

Independent Variables

Mediterranean diet
Adherence was determined by a 150-item questionnaire using a zero- to nine-point diet scale that stratified respondents as having low adherence (less than four points) and moderate to high adherence (more than four points).

Control Variables

Age
Gender
Education
Family history of obesity
Smoking
Mode of infection
Diet
Current antiretroviral regimen
Physical activity assessed using the short version of the International Physical Activity Questionnaire.

Description of Actual Data Sample:

Initial N

169 adults met eligibility criteria.

Attrition (Final N)

136 adults (80%) agreed to participate, 108 (79%) males.

Age

Median age, 43 years.

Anthropometrics

Median duration of CART was 47 months
Median CD4 cell count, 356.5 cells per mm³
Median viral load, 5.6 log₁₀ per ml.

Location

Croatia.

Summary of Results:

Key Findings

Lipoatrophy was present in 41% and lipohypertrophy in 32% of participants
Non-smokers with a dietary score of more than four had the lowest risk for lipoatrophy
Stavudine use, female gender and duration of CART were also independently associated with a higher risk of lipoatrophy
There was no association between the Mediterranean diet score and lipoatrophy
A dietary score of more than four was associated with lower risk of lipohypertrophy (adjusted odds ratio = 0.3, 95% confidence interval: 0.1 to 0.7, P=0.012)
Female gender, longer duration of CART, and longer known duration of HIV infection prior to CART were also independently associated with higher risk of lipohypertrophy.

Author Conclusion:

In summary, we found that 75 (55%) of our patients who were taking CART for at least 12 months had clinical signs of body-shape changes. Croatian patients treated with CART and adhering to a Mediterranean diet might have a lower risk of developing body-shape changes. Our exploratory results need to be confirmed by larger studies and in other populations.

Funding Source:

University/Hospital:

University Hospital of Infectious Diseases, Croatia

Reviewer Comments:

National sample of Croatians. Authors note that the number of patients was relatively small in certain subgroups.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	N/A
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	N/A

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		Yes
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	Yes
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	Yes
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	N/A
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		Yes
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	N/A
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	Yes
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	Yes
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	N/A
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	Yes
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	N/A
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	N/A
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	N/A
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	N/A
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	N/A
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	N/A
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	Yes
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.2.	Was the study free from apparent conflict of interest?	Yes